Amarin Corp Plc (AMRN)

[Biobillionair]

I believe this is the beginning of a settlement. Here's cleaned up copy and pace of PROPOSED JUDGEMENT.
[PROPOSED] JUDGMENT
Case 3:20-cv-00421-MMD-CLB Document 11 Filed 07/24/20 Page 1 of 5

icosapent ethyl capsules purportedly bioequivalent to Amarin’s VASCEPA® product (“Hikma’s 0.5 g ANDA product”), containing a Paragraph IV certification with respect to, inter alia, U.S. Patent No. 8,293,728 (“the ‘728 Patent”), U.S. Patent No. 8,318,715 (“the ‘715 Patent”), U.S. Patent No. 8,357,677 (“the ‘677 Patent”), U.S. Patent No. 8,367,652 (“the ‘652 Patent”), U.S. Patent No. 8,377,920 (“the ‘920 Patent”), U.S. Patent No. 8,415,335 (“the ‘335 Patent”), U.S. Patent No. 8,426,399 (“the ‘399 Patent”), U.S. Patent No. 8,440,650 (“the ‘650 Patent”), U.S. Patent No. 8,518,929 (“the ‘929 Patent”), U.S. Patent No. 8,524,698 (“the ‘698 Patent”), U.S. Patent No. 8,546,372 (“the ‘372 Patent”), and U.S. Patent No. 8,617,594 (“the ‘594 Patent”), (collectively, the “Patents-in-Suit”); Whereas Hikma’s ANDA No. 209457 for approval of an icosapent ethyl product in a 1 g dosage strength (“Hikma’s 1 g ANDA product”), is currently the subject of the matter styled Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA, Inc., No. 2:16-cv-02525-MMD-NJK (D. Nev. filed Oct. 31, 2016) (the “2525 Action”); Whereas in the 2525 Action, Amarin initially alleged that Hikma’s 1 g ANDA product infringes the Patents-in-Suit, as well as U.S. Patent Nos. 8,399,446 (“the ‘446 Patent”) and 8,431,560 (“the ‘560 Patent”); Whereas in the 2525 Action, Amarin subsequently narrowed the asserted patents and claims, and ultimately alleged only that Hikma’s 1 g ANDA product infringes Claims 1 and 16 of the ‘728 Patent; Claim 14 of the ‘715 Patent; Claims 1 and 8 of the ‘677 Patent; Claim 1 of the ‘652 Patent; Claims 4 and 17 of the ‘560 Patent; and Claims 1 and 5 of the ‘929 Patent; Whereas, on March 30, 2020, the Court entered a judgment in the 2525 Action concluding that the asserted claims were infringed by the filing of ANDA No. 209457 but invalid as obvious—namely, Claims 1 and 16 of the ‘728 Patent; Claim 14 of the ‘715 Patent; Claims 1 and 8 of the ‘677 Patent; Claim 1 of the ‘652 Patent; Claims 4 and 17 of the ‘560 Patent; and Claims 1 and 5 of the ‘929 Patent; Whereas Amarin timely appealed the judgment in the 2525 Action, and that appeal is pending before the United States Court of Appeals for the Federal Circuit; Whereas Amarin has brought the above-captioned action, Case No. 3:20-cv-421-MMDCLB, asserting that Hikma’s 0.5 g ANDA product infringes the Patents-in-Suit (see ECF No. 1); Whereas Hikma has represented that, but for the respective amounts of active ingredient in each product, the formulation of Hikma’s 0.5 g ANDA product is identical to the formulation of Hikma’s accused 1 g ANDA product; Whereas Hikma has represented that the proposed prescribing information for Hikma’s 0.5 g product is identical to the prescribing information for Hikma’s 1 g ANDA product; Whereas Hikma and Amarin anticipate that the factual and legal issues surrounding alleged infringement of the Patents-in-Suit by Hikma’s 0.5 g ANDA product will be substantially identical to the issues surrounding alleged infringement of the Patents-in-Suit by Hikma’s accused 1 g ANDA product; Whereas Hikma and Amarin anticipate that the factual and legal issues surrounding alleged invalidity of the Patents-in-Suit in the above-captioned action, Case No. 3:20-cv-421-MMD-CLB, will be substantially identical to the issues surrounding alleged invalidity in the 2525 Action; Therefore, Hikma and Plaintiffs jointly agree and stipulate as follows:

1. Subject to Amarin’s rights to appeal referenced in paragraph 6 below, the final judgment of this Court in the 2525 Action on the merits of Amarin’s contentions of alleged infringement of the Patents-in-Suit by Hikma’s 1 g ANDA product shall also be binding on Hikma and Amarin as though that judgment were also made in the above-captioned action, Case
No. 3:20-cv-421-MMD-CLB as to Hikma’s 0.5 g ANDA product.

2. Subject to Amarin’s rights to appeal referenced in paragraph 6 below, the final judgment of this Court in the 2525 Action on the merits of the contentions of alleged invalidity of the Patents-in-Suit shall also be binding on Hikma and Amarin as though that judgment were also made in the above-captioned action, Case No. 3:20-cv-421-MMD-CLB.

3. Because of the parties’ agreement that the judgment in the 2525 Action will be binding in this action, the Court enters judgment on infringement in this action based on the judgment in the 2525 Action as follows: The filing of ANDA No. 209457 infringed the following claims: Claims 1 and 16 of the ‘728 Patent; Claim 14 of the ‘715 Patent; Claims 1 and 8 of the ‘677 Patent; Claim 1 of the ‘652 Patent; and Claims 1 and 5 of the ‘929 Patent.

4. Because of the parties’ agreement that the judgment in the 2525 Action will be binding in this action, the Court enters judgment on obviousness in this action in favor of Defendants and against Plaintiffs on the same grounds as the judgment in the 2525 Action, in which the following claims were adjudicated as invalid as obvious under 35 U.S.C. § 103: Claims 1 and 16 of the ‘728 Patent; Claim 14 of the ‘715 Patent; Claims 1 and 8 of the ‘677 Patent; Claim 1 of the ‘652 Patent; and Claims 1 and 5 of the ‘929 Patent.

5. All other claims in the above-captioned action, including with respect to the ‘920; ‘335; ‘399; ‘650; ‘698; ‘372; and ‘594 Patents, are dismissed without prejudice.

6. Plaintiffs expressly reserve and retain any and all rights to appeal from this judgment, and otherwise to seek appropriate modification of this judgment, should the final judgment in the 2525 Action be vacated and/or reversed by the United States Court of Appeals for the Federal Circuit or the Supreme Court. Defendants will not oppose a request to modify this judgment to correspond with any modification of the judgment in the 2525 Action, either by this Court or on appeal.

7. To the extent the filing of the above-captioned action initiated any 30-month stay of FDA approval under the Hatch-Waxman Amendments, Amarin does not contest that FDA may determine that any such stay is both terminated by this judgment and does not prevent final approval of Hikma’s 0.5 g ANDA product.

8. JUDGMENT IS ENTERED accordingly in favor of Defendants and against
Plaintiffs.

IT IS SO ORDERED.
Dated: _____________________ ___________________________________
United States District Judge
Respectfully submitted,
/s/ Adam Hosmer-Henner
Adam Hosmer-Henner (Nev. Bar No. 12779)
Chelsea Latino (Nev. Bar No. 14227)
MCDONALD CARANO LLP
100 W. Liberty Street, Tenth Floor
Reno, NV 89501
Tel.: [phone] / Fax: [phone]
[e-mail];
[e-mail]
Christopher N. Sipes (pro hac vice forthcoming)
Michael N. Kennedy (pro hac vice forthcoming)
Megan P. Keane (pro hac vice forthcoming)
COVINGTON & BURLING LLP
One CityCenter, 850 Tenth Street, NW
Washington, DC 20001
Tel: [phone] / Fax: [phone]
E-mail: [e-mail], [e-mail],
[e-mail]
Attorneys for Plaintiffs Amarin Pharma, Inc.
and Amarin Pharmaceuticals Ireland Limited
/s/ W. West Allen
W. West Allen (Nev. Bar No. 5566)
HOWARD & HOWARD
ATTORNEYS PLLC
3800 Howard Hughes Parkway, Suite 1000
Las Vegas, NV 89169
Tel: [phone]
Email: [e-mail]
Attorneys for Hikma Pharmaceuticals USA
Inc. and Hikma Pharmaceuticals
International Limited